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Women Informed to Screen Depending on Measures of Risk (Wisdom Study)

Study acronym: WISDOM
StatusRecruiting
PhaseNot applicable
Started2016-08-31
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 36 months later Sep 1, 2026 → Sep 30, 2029
See other at-risk trials from University of California, San Francisco

Amendment history

2026-09-22
Primary completion pushed: 2026-09-01 → 2029-09-30
Completion pushed: 2026-09-01 → 2029-09-30
2025-11-19
Study Status, Study Description, Outcome Measures, Eligibility v22
Eligibility criteria+55 characters
Inclusion Criteria: Female* Age 30 years to 74 years old** Reside in California,the NorthUnited Dakota, South Dakota, Iowa, Minnesota, Alabama, Louisiana, Illinois OR have coverage from a participating health planStates**.* NOTE*: As of 2019, we are now enrolling all persons who ide [...] t birth and gender identity in the baseline survey. NOTE**: DependingEligibility onfrom funding2016 for- studyOctober services,2023 recruitmentincluded willages expand nationwide, therefore criteria40-74 (cWISDOM 1.0) willand notexpanded applyto ifage funding30 allowsin October 2023 (WISDOM 2.0). NOTE***: As of 2019 [...] [...]
Secondary endpoints12 entries, revised
Late-stage cancerscancer rate and interval cancer rate IntervalRate of stage IIA cancers Breast imaging rate Mammogram recall rate
Study description+1,058 characters
[...] disease. In close collaboration with patient advocates, the WISDOM 1.0 study has been designed as a 5-year, preference-tolerant, 6 [...] University of California, and policy-making organizations. WISDOM 1.0 trial was originally designed to randomize 65,000 women and be completed after five years to provide a median of ~3 years of exposure time in each randomized arm. However, due to slow initial accrual, trial duration was extended to up to ten years enabling a sample size reduction with mai [...] The study hypothesizes that risk-based screening will be an [...] d implementation that will benefit women across t [...]
2025-06-20
Study Status, Sponsor/Collaborators v21
Collaborators7 to 8 entries
Breast Cancer Research Foundation
2025-04-28
Study Status, Contacts/Locations v20
Primary completion date2025-09-01→2026-09-01
Completion date2025-09-01→2026-09-01
Study sitescontacts updated at 1 of 11 sites
2025-01-17
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 11 sites
Show 18 earlier versions
2024-11-13
Study Status v18
Primary completion date2025-12-31→2025-09-01
Completion date2025-12-31→2025-09-01
2024-10-07
Study Status, Contacts/Locations v17
Primary completion date2025-10-31→2025-12-31
Completion date2025-10-31→2025-12-31
Study sitesdetails revised at 1 of 11 sites
2024-05-06
Study Status, IPDSharing v16
Primary completion date2024-12-01→2025-10-31
Completion date2025-03-01→2025-10-31
2024-04-25
Study Status, Contacts/Locations v15
Study sitescontacts updated at 1 of 11 sites
2024-04-18
Study Status, Sponsor/Collaborators, Contacts/Locations v14
Study sitescontacts updated at 1 of 11 sites
Collaborators6 to 7 entries
United States Department of Defense
2024-03-05
Study Status, Eligibility, Contacts/Locations v13
Eligibility criteriarevised
Inclusion Criteria: Female* Age 4030 years to 74 years old Reside in California, North Dakota, S [...]
Study sitesdetails revised at 3 of 11 sites
2023-12-13
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 11 sites
2022-12-06
Study Status, Contacts/Locations v11
Study sites10→11
2021-11-08
Study Identification, Study Status, Sponsor/Collaborators, Outcome Measures, Eligibility v10
Eligibility criteria+582 characters
Inclusion Criteria: Female (biologically female at birth)* Age 40 years old to 74 years old Reside in California, North Dakota, South Dakota, Iowa, Minnesota, Alabama, Louisiana, Illinois OR have coverage from a participating health plan**. NOTE*: As of 2019, we are now enrolling all persons who identify as female, and will capture both their sex at birth and gender identity in the baselin [...] Exclusion Criteria: Prior breastBreast cancer or ductal carcinoma in situ (DCIS) diagnosis Prior prophylactic bilateral mastectomy Inability to provide consent Non-English or Spanish proficiency (Spanish adde [...] [...]
Secondary endpointsdetails revised at 1 of 12 entries
Collaborators5 to 6 entries
Safeway Foundation
2021-02-25
Study Identification, Study Status, Contacts/Locations v9
Primary completion date2022-12→2024-12-01
Completion date2022-12→2025-03-01
Study sites9→10
2020-03-16
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v8
Primary completion date2020-12→2022-12
Completion date2020-12→2022-12
Study sites6→9
InterventionsComplete a health questionnaire (Other), Provide a saliva sample for genetic testing (Genetic), Screening advice based on a basic risk…→Complete a health questionnaire (Other), Provide a saliva sample for genetic testing (Device), Screening advice based on a basic risk…
Eligibility criteria-33 characters
Inclusion Criteria: Female (biologically female at birth) Age 40 years old to 74 years old Reside in California or receive care at a Sanford Health site Exclusion Criteria: Prior breast cancer or DCIS diagnosis Non-English or Spanish proficiency (plans to expand to Spanish byadded yearJune 22019)
Collaborators4 to 5 entries
National Cancer Institute (NCI)
2018-02-07
Study Identification, Study Status, Oversight, Conditions, Study Design v7
Study title+15 characters
Women Informed to Screen Depending on Measures of Risk (Wisdom Study)
2017-11-30
Study Status, Conditions, Contacts/Locations v6
Study sitesdetails revised at 2 of 6 sites
2017-08-04
Study Status, Eligibility, Contacts/Locations v5
Eligibility criteria-109 characters
Inclusion Criteria: Female Age 40 years old to 74 years old ReceiveReside breastin screeningCalifornia or receive care at ana AthenaSanford Health site (UCSF, UCSD, UCD, UCLA, UCI, Sanford): for the first 1-2 years of the study; expansion to other medical care sites after year 1 Exclusion Criteria: Prior breast cancer or DCIS diagnosis N [...]
2017-04-25
Enrolling by Invitation→Recruiting Study Status, Contacts/Locations v4
Trial statusEnrolling by Invitation→Recruiting
Start date2016-08→2016-08-31
Study sitesdetails revised at 6 of 6 sites
2016-12-21
Study Status, Eligibility v3
Eligibility criteria-145 characters
Inclusion Criteria: Female Age 40 years old to 74 years old Prior mammogram within the last 2 years (BIRADS 0,1,2,3, or 4) or mammogram completed upon joining the study Coverage by a participating insurer Receive breast screening at an Athena site (UCSF, UCSD, UCD, [...]
2016-11-21
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start date2016-01→2016-08
Study sitescontacts updated at 6 of 6 sites
2015-12-22
Study Status, Study Description, References v1
Study description+77 characters
[...] educe mortality from breast cancer. A number of advances in ourthe understanding of breast cancer biology, and screening in general, have led to calls to revise and improve ournational screening strategystrategies (Esserman et al., 2014). In 2009, the US Preventive Service [...] nfused, and some have stopped screening altogether. Despite oura vastly improved understanding of breast cancer risk, the on [...] tors as well (Darabi, et al., 2012). Therefore, advances in ourthis understanding of breast cancer biology, risk assessment, and imaging have providedenabled usthe withcreation of better tools and suffic [...] [...]
Publicationsdetails revised at 7 of 13 entries
2015-12-02
Original filing
Most physicians still use a one-size-fits-all approach to breast screening in which all women, regardless of their personal history, family history or genetics (except BReast CAncer gene (BRCA) carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit women by detecting cancers early when they are easier to treat, but they are not perfect. Recent news stories have discussed some of the potential harms: large numbers of positive results that cause stressful recalls for additional mammograms and biopsies. With the current screening approach, half of the women who undergo annual screening for ten years will have at least one false positive biopsy. Potentially more important are cancer diagnoses for growths that might never come to clinical attention if left alone (called "overdiagnosis"). This can lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast cancers detected today may fall into the category of "overdiagnosis." The WISDOM 1.0 study compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so that even women who might be nervous about being randomly assigned to receive a particular type of care (a procedure that is typical in clinical studies) will still be able to participate by choosing the type of care they receive. For participants in the risk-based screening arm, each woman will receive a personal risk assessment that includes her family and medical history, breast density measurement and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive more frequent screening, while women with a lower personal risk would receive less frequent screening. No woman will be screened less than is recommended by the USPSTF breast cancer screening guidelines. If this study is successful, women will gain a realistic understanding of their personal risk of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe this study has the potential to transform breast cancer screening in America. Starting in Spring 2023, WISDOM's design shifted to remove the randomized option, but will continue with the preference/self-selection option for participation (WISDOM 2.0). Participants will therefore continue to choose their study arm (Personalized or Annual) rather than have the option to be randomized. This study design change was made after review of the WISDOM 1.0 data by an independent monitoring committee, which indicates that personalized screening does not cause harm. WISDOM 2.0 has also lowered the eligibility to ages 30-74. Women ages 30-39 will only be offered to join the Personalized Arm.
Trial Details
NCT Number NCT02620852
Lead Sponsor University of California, San Francisco
Collaborators: Patient-Centered Outcomes Research Institute, Robert Wood Johnson Foundation, Color Genomics, Inc., Salesforce, National Cancer Institute (NCI), Safeway Foundation, United States Department of Defense, Breast Cancer Research Foundation
Conditions Breast Cancer Screening, Breast Carcinoma in Situ, Breast Cancer
Enrollment 100,000 participants
Start Date 2016-08-31
Primary Completion 2029-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-21